SPL v3
SPL
SPL Set ID 41da6725-a19e-4343-b2e1-2fbf27e8167f
Route
TOPICAL
Published
Effective Date 2012-01-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (1 mL)
Inactive Ingredients
Eucalyptus Oil Lemon Oil Orange Oil Peppermint Oil Rosemary Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-02-01
Description

camphor 3.1%

Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

For the temporary relief of minor aches and pains of muscles and joints associated with simple backaches, arthritis, strains, bruises and sprains.

Dosage and Administration

Directions

  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, massaging area gently
  • wash hands after application
  • after applying, wait 10 minutes and then wash area if desired to remove scent.  This will not decrease effectiveness.
  • children under 2 years of age: consult a physician


Description

camphor 3.1%

Section 44425-7

store in a cool, dry place

Section 50565-1

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Section 50567-7

When using this product

  • avoid contact with eyes

Section 50570-1

Do not

  • apply to wounds or damaged skin
  • bandage tightly

Section 51727-6

Aloe Vera Oil, Eucalyptus Globulus Leaf Oil, Lemon Peel Oil (Citrus Medica Limonum), Orange Oil (Citrus Aurantium Dulcis), Peppermint Oil (Mentha Piperita), Rosemary Leaf Oil (Rosmarinus Officinalis)

Section 51945-4

Section 53413-1

Questions or comments?

1.877.310.4173 9:00am-5:00pm EST M-F

allnaturalpainmanagement.com

Section 53414-9

If pregnant or breast feeding, ask a health professional before use.



Section 55105-1

Topical Analgesic

Section 55106-9

camphor 3.1%

Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of minor aches and pains of muscles and joints associated with simple backaches, arthritis, strains, bruises and sprains.

Dosage and Administration (34068-7)

Directions

  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, massaging area gently
  • wash hands after application
  • after applying, wait 10 minutes and then wash area if desired to remove scent.  This will not decrease effectiveness.
  • children under 2 years of age: consult a physician


Warnings and Precautions (34071-1)

For external use only.

Section 44425-7 (44425-7)

store in a cool, dry place

Section 50565-1 (50565-1)

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Section 50567-7 (50567-7)

When using this product

  • avoid contact with eyes

Section 50570-1 (50570-1)

Do not

  • apply to wounds or damaged skin
  • bandage tightly

Section 51727-6 (51727-6)

Aloe Vera Oil, Eucalyptus Globulus Leaf Oil, Lemon Peel Oil (Citrus Medica Limonum), Orange Oil (Citrus Aurantium Dulcis), Peppermint Oil (Mentha Piperita), Rosemary Leaf Oil (Rosmarinus Officinalis)

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

1.877.310.4173 9:00am-5:00pm EST M-F

allnaturalpainmanagement.com

Section 53414-9 (53414-9)

If pregnant or breast feeding, ask a health professional before use.



Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

camphor 3.1%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:24.484022 · Updated: 2026-03-14T22:52:58.895821